Hui-I K. Tom, PhD U.S. FDA

Dr. Hui-I Tom is a Senior Chemist in Office of Quality Surveillance (OQS) in Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration. Dr. Tom serves as the lead scientist and a point of contact for post-market deviation reporting of CDER-regulated biologics and participates in process improvement and policy development initiatives within OQS. Dr. Tom has over 20 years of experience in molecular biology research and GMP biologic drug development. Prior to joining the Agency, Dr. Tom held biologics development positions with increasing responsibility in the biopharmaceutical GMP industry, culminating as Scientific Officer and Director for Bioanalytical Operations. Dr. Tom did her postdoctoral fellowships with Dr. Carol Greider in Johns Hopkins University School of Medicine. Dr. Tom received her PhD in molecular biology and biochemistry from the School of Medicine and Dentistry at the University of Rochester. She attended the University of California at Berkeley for her undergraduate studies majoring in molecular biology and biochemistry.